Surgical repair kit and its method of use

ABSTRACT

A suture passer comprises a longitudinally extending hollow cannula having a central passage slidingly receivable of a surgical suture; a manually graspable handle connected to the hollow cannula for manipulation thereof, the handle having an upper surface; first guide means, connected to the upper surface of the handle, proximate a proximal end of the handle for releasably, guidingly, holding the surgical suture; second guide means, connected to the upper surface of the handle, distal to the first guide means, for releasably, guidingly, holding the surgical suture. The suture passer can be provided in a kit, for use in the suturing of internal tissue, along with a cannula bender, various hollow surgical needles and surgical suture material. The suture passer finds particular use in the suturing of internal tissues which are at least partially accessible through a body cavity, e.g., arthroscopic surgery.

FIELD OF THE INVENTION

[0001] The present invention relates to medical devices for performingsurgery and a surgical repair kit containing the same. Moreparticularly, the present invention is directed to a surgical repair kituseful for performing arthroscopic meniscal repairs.

BACKGROUND OF THE INVENTION

[0002] Menisci are tough rubbery “C” shaped cartilage cushions that areattached by ligaments to the top (plateau) of the tibia. They preventthe surfaces of the tibia and femur from grinding against each other andact as the shock absorbers in the knee.

[0003] Meniscal tears are a common problem in the United States,especially among amateur and professional athletes. While menisci arealso located in the shoulder, the most common meniscus injury occurs inthe knee. There are two menisci in each knee. Each year, tens ofthousands of people suffer meniscal tears, particularly in or at thesite of one or both knees. If these tears are not repaired, there may bea progressive deterioration of the cartilage, leading to the painfulrubbing and wearing of bones which had previously been covered bycartilage. This, in turn, leads to inflammatory synovitis, arthritis andother debilitating ailments. Consequently there are at least 30,000 to40,000 meniscal excisions or repairs to the shoulder and the kneeperformed each year.

[0004] Men and women between the ages of 18 and 45 experience themajority of meniscal tears, usually during athletic activity, such aswhen twisting, cutting, pivoting, decelerating or when being tackled.When torn, the meniscus may have a longitudinal, horizontal, or radial(“parrot beak”) tear.

[0005] The damaged meniscus may be diagnosed with the assistance or useof magnetic resonance imaging (MRI) and/or an arthroscopic examination.Arthroscopy enables a surgeon to look into the joint using a miniaturevideo camera. In many cases, torn fragments of the meniscus are removedarthroscopically. In other cases, a small tear at the periphery of themeniscus with a very swollen knee joint may be treated by draining thejoint, temporarily restricting the use of the knee, and slowly havingthe patient begin rehabilitative exercises.

[0006] However, in other cases, the tears in the meniscus do requiresurgical repair, normally by sewing the torn sections of the meniscustogether. The use of the arthroscope greatly aids in the surgical repairof the meniscus by allowing the surgeon to better visualize the smallareas between which the torn meniscus lies. The arthroscope enables thesurgeon to visualize the interior of the joint and to perform surgerythrough small puncture holes without having to open the joint as hasbeen done in the past.

[0007] A number of surgical tools have been developed to assist insuturing, and in particular the suturing of the meniscus.

[0008] U.S. Pat. No. 2,808,055 (Thayer) discloses a surgical stitchinginstrument which accommodates a bobbin of suture material and includemeans to feed the suture material to a needle. A slidable thread movingmember is provided for advancing the suture material through the needle.

[0009] U.S. Pat. No. 3,476,114 (Shannon, et al.) discloses a ligatingimplement comprising an elongated instrument through which a ligaturepasses to form a loop at one end with a disc. The disc provides a meanswhereby the loop may be drawn tight above a severed vessel or the like.

[0010] U.S. Pat. No. 3,476,115 (Graeff, et al.) discloses a ligatingimplement as in Shannon, et al., and includes severing means to preventoverstressing of the locking disc during tightening of the noose.

[0011] U.S. Pat. No. 4,493,323 (Albright, et al.) discloses a suturingdevice and a method for its use in arthroscopic surgery. The suturingdevice comprises an elongated tube and plunger which are used to holdand advance a pair of needles united by a length of suture material.

[0012] U.S. Pat. No. 4,641,652 (Hutterer, et al.) discloses anapplicator for tying sewing threads which comprises a helical tubularcoil connected to a shaft having an axial passage. A catcher loop isextendable through the shaft to catch a sewing thread inserted manuallyinto the coil passage.

[0013] U.S. Pat. No. 4,935,027 (Yoon) discloses surgical instruments andmethods for affecting suturing of tissue controlled from a positionremote from the suture site. The invention provides for the continuousfeeding of suture material through opposed forcep jaw members betweenwhich the tissue segments are interposed.

[0014] U.S. Pat. No. 5,112,308 (Olsen, et al.) discloses a medicaldevice for and a method of endoscopic surgery. The device includes adilator having a tapered end and a central passage which accommodates aguide wire for directing the dilator. This device does not include anymeans whereby the guide wire may be secured to the dilator or otherwisemanipulated in conjunction therewith.

[0015] U.S. Pat. No. 4,779,616 (Johnson) discloses a method for snaggingan end of a surgical suture during arthroscopic surgery, comprisingdeploying a distal end of a cylindrical cannula adjacent to the end ofthe suture within the body and passing a resilient loop through thecannula to snag the suture.

[0016] U.S. Pat. Nos. 4,890,615, 4,923,461 and 4,957,498 (Caspari, etal.) discloses a suturing instrument and method of use in arthroscopicsurgery. The suturing instrument includes a hollow needle forpenetrating tissue to be sutured within the body while the tissue isclamped between relatively moveable jaws and a suture feed mechanism forfeeding suture material through the hollow needle. The jaws can beopened and the suturing instrument withdrawn from the body, pulling thefree end segment of the suture material with the instrument.

SUMMARY OF THE INVENTION

[0017] It is an object of the present invention to provide a surgicalrepair kit. In particular, it is an object of the present invention toprovide a surgical repair kit which is particularly suited for therepair of torn menisci.

[0018] It is still yet another object of the present invention toprovide a suture passer having means for positioning of the suture.

[0019] It is still yet another object of the present invention toprovide a parallel needle guide to allow for an easier and moresuccessful placement of a second needle in close proximity to the firstneedle that has been previously inserted in the area of a tissue tear.

[0020] While the present invention is primarily concerned with therepair of torn menisci, the repair kit, the parallel needle guide, andthe suture passer may be used in other surgical procedures, e.g. forsuturing internal tissue at least partially accessible through a bodycavity.

[0021] The suture passer of the invention comprises a longitudinallyextending hollow cannula having a central passage slidingly receivableof a surgical suture and a manually graspable handle connected to thehollow cannula for manipulation thereof. The suture passer has a firstguide means connected to an upper surface of the handle, proximate to aproximate end of the handle for releasably, guidingly holding thesurgical suture, and a second guide means connected to the upper surfaceof the handle, distal to the first guide means for releasably, guidinglyholding the surgical suture.

[0022] In one embodiment of the invention, the hollow cannula isconnected to the upper surface of the handle and the hollow cannulaterminates at a rearward opening between the first and second guidemeans.

[0023] In another embodiment of the invention, the hollow cannula isreceived within a bore formed in the handle, with the bore terminatingat an opening in the upper surface of the handle between the first andsecond guide means.

[0024] The guide means may be loops which are either parallel ortransverse to the longitudinally extending hollow cannula. In analternative embodiment, the second guide means may consist of aplurality of bent fingers lying in parallel planes.

[0025] The guide means serve as means about which the suture is passedso it may be manipulated longitudinally with respect to the cannula. Thediameter of the central passage of the cannula is such that the tip of aspinal or similar needle into which the suture is directed may fit intothe cannula and is large enough to allow the sliding passage of twosurgical sutures (i.e. the two limbs of a single surgical suture). Inthe method of use, the suture passer is used in surgical manipulations,and in particular meniscal repairs or other arthroscopic procedures todirect a suture within a joint space with a greater degree of precisionthan available by current methods.

[0026] When the two limbs of a surgical suture are within the cannula,the guide means function to separate the two limbs. Separation of thelimbs of the surgical suture allows independent manipulation of thesuture limbs. Digital manipulation of the surgical suture between theproximal and distal guide means causes longitudinal passage of one limbof the surgical suture within the cannula, i.e. friction between thedigit and the said suture will cause the said suture to slide along thetop surface of the handle, into or out of the cannula, when manipulateddigitally.

[0027] The surgical repair kit of the present invention comprises asuture passer, as previously described, at least two surgical needles ofpredetermined length and at least one stylet for each surgical needle.Preferably, the surgical repair kit includes three surgical needles,with one of the surgical needles having a length greater than that ofthe other needles.

[0028] In a preferred embodiment, the suture passer is provided with ametal cannula, and the surgical repair kit includes a cannula bender forbending the metal cannula in a desired manner. The cannula bendercomprises a base and a pair of upwardly stepped symmetrical bolsterspositioned on top of the base allowing the cannula to be bent to theright or to the left, each step of each bolster having a predeterminedradius of curvature wherein the radius of curvature of each step issmaller than the radius of curvature of the step immediately below.

[0029] Additionally, the surgical repair kit of the present inventionmay further include a parallel needle guide for guiding the surgicalneedles for desired placement relative to each other. The parallelneedle guide comprises at least three longitudinally extending, hollowtube-shaped units longitudinally adhered to each other, in a plane,parallel to one another, each of the tube-shaped units slidinglyreceivable of a surgical needle therethrough.

[0030] The present invention also provides methods for the suturing ofinternal tissue which is at least partially accessible through a bodycavity. A first method comprises the steps of:

[0031] (A) providing at least one suture having a first limb and asecond limb;

[0032] (B) providing a suture passer comprising a longitudinallyextending hollow cannula having a distal opening, a proximal opening anda central passage slidingly receivable of a surgical suture;

[0033] (C) introducing the distal end of the cannula into a body cavityat least partially accessing internal tissue to be sutured;

[0034] (D) identifying a first insertion site for passing a first limbof a suture through the internal tissue to be sutured;

[0035] (E) inserting a first hollow needle through the first insertionsite, the hollow needle extending from outside the body through thefirst insertion site into the body cavity;

[0036] (F) identifying a second insertion site for passing a second limbof the suture through the internal tissue to be sutured;

[0037] (G) inserting a second hollow needle through the second insertionsite, the hollow needle extending from outside the body through thesecond insertion site into the body cavity;

[0038] (H) passing the second limb of the suture through the firsthollow needle into the distal opening of the cannula until it exits theproximal opening of the cannula;

[0039] (I) feeding the second limb of the suture back into the cannulathrough the proximal opening;

[0040] (J) passing the second limb of the suture through the hollowcannula into the second hollow needle until it exits the needle externalof the body;

[0041] (K) drawing the suture through the cannula into the body cavity;

[0042] (L) removing the first and second needles by drawing themoutwardly of the body cavity;

[0043] (M) tying the limbs of the suture; and

[0044] (N) repeating steps (D)-(M) until a surgically sufficient numberof sutures have been tied.

[0045] A second method comprises the steps of:

[0046] (A) providing at least one suture having a first limb and asecond limb;

[0047] (B) providing a suture passer comprising a longitudinallyextending hollow cannula having a distal opening, a proximal opening anda central passage slidingly receivable of a surgical suture;

[0048] (C) loading the suture passer with a surgical suture such that anend of the first limb of the suture and an end of the second limb of thesuture each protrude from the distal end of the cannula;

[0049] (D) introducing the distal end of the cannula into a body cavityat least partially accessing internal tissue to be sutured;

[0050] (E) identifying a first insertion site for passing the first limbof the suture through the internal tissue to be sutured;

[0051] (F) inserting a first hollow needle through the first insertionsite, the hollow needle extending from outside the body through thefirst insertion site into the body cavity;

[0052] (G) identifying a second insertion site for passing a second limbof the suture through the internal tissue to be sutured;

[0053] (H) inserting a second hollow needle through the second insertionsite, the hollow needle extending from outside of the body through thesecond insertion site into the body cavity;

[0054] (I) introducing the end of the first limb of the suture into thefirst hollow needle until it exits the first hollow needle outside thebody;

[0055] (J) introducing the end of the second limb of the suture into thesecond hollow needle until it exits the second hollow needle outside thebody;

[0056] (K) drawing the suture through the cannula into the body cavity;

[0057] (L) removing the first and second hollow needles by drawing themoutwardly of the body cavity;

[0058] (M) tying the limbs of the suture; and

[0059] (N) repeating steps (C)-(M) until a surgically sufficient numberof sutures have been tied.

BRIEF DESCRIPTION OF THE DRAWINGS

[0060]FIG. 1 is a side view of the suture passer.

[0061]FIG. 2 is a top view of another embodiment of the suture passer.

[0062]FIG. 3 is a side view of the suture of FIG. 2.

[0063]FIG. 4 is a frontal view of the handle of the embodiment of thesurgical suture passer of FIG. 3.

[0064]FIG. 5 is a cross section of the handle of the surgical suturepasser.

[0065]FIG. 6 is a side view of another embodiment of the surgical suturepasser.

[0066]FIG. 7A is a side view and FIG. 7B is a top view of anotherembodiment of the surgical suture passer.

[0067]FIG. 8A is an enlarged side view of a tip of a spinal needle andFIG. 8B is an enlarged side view of a tip of an epidural needle.

[0068]FIG. 9 is a side view of a parallel needle guide.

[0069]FIG. 10 is a frontal view of a parallel needle guide.

[0070]FIG. 11 is a side section view of a needle containing a stylet.

[0071]FIG. 12 is a frontal view of a cannula bender.

[0072]FIG. 13 is a frontal view illustrating the use of the cannulabender.

[0073]FIG. 14-FIG. 26 are cross-sectional top views at various stages ofan operation where the middle third of the meniscus is being repaired.

[0074]FIG. 27-FIG. 31 are cross-sectional top views at various stages ofan operation where the posterior region of the meniscus is beingrepaired.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0075] FIGS. 1-7 illustrate the meniscal suture passer 1, used for thepassage of a suture in a confined area of the body during surgery. Thesuture passer 1 comprises a longitudinally extending hollow cannula 2having a central passage slidingly receivable of a surgical suture, anda manually graspable handle 3 connected to the hollow cannula 2 formanipulation thereof. A first guide means is connected to the uppersurface of the handle 3 for releasably, guidingly holding the surgicalsuture. A second guide means for guidingly holding the suture, is alsoconnected to the upper surface of the handle 3. The second guide meansis distal to the first guide means. The suture passer 1 in FIGS. 1-6comprises a cannula 2, a handle 3, a rearward opening 4 near theproximal end of the handle 3, a proximal loop 5, and a distal loop 6.The proximal loop 5 serves as the first guide means, and the distal loop6 serves as the second guide means. Proximal loop 5 preferably comprisesa single turn open wire loop having a first axis of rotation of the loopand distal loop 6 is preferably a 1½ pigtail open wire loop having asecond axis of rotation of the loop. The loops are preferably parallelto one another. In one embodiment, the wire loops 5 and 6 are preferablyperpendicular to the handle 3 with the first axis of rotation and thesecond axis of rotation are transverse to said longitudinally extendinghollow cannula 2. In another embodiment, the axes of rotation of loops 5and 6 are parallel to the longitudinally extending cannula 3. Near theproximal end of the handle there is an opening 4 which leads from thehandle 3 to the cannula 2. The handle is preferably provided withgripping means and is preferably knurled 7, so that the surgeon has abetter grip on the suture passer 1.

[0076] The cannula 2 may be attached and enter through an opening at theconcentric center 8 of the handle 3 as shown in FIG. 1. The hollowcannula 2 is received within a bore formed in the handle 3 with the bore8 terminating at an opening 4 in the upper surface 9 of the handle 3intermediate the first and second guide means. In an alternativeembodiment the cannula may be connected to the upper surface 9 of thehandle 3, as shown in FIG. 3. In this embodiment of the invention, thereis no opening into or through the handle 3. Instead, the hollow cannula2 terminates at a rearward opening 10 between the first and second guidemeans directly on top of the handle 3. Additionally, in the embodimentof FIG. 1, the handle of the suture passer is rounded, whereas in theembodiment of FIGS. 3 and 4, the suture passer handle 3 is flattened onthe side upon which the proximal end 10 of the cannula 2 resides.Additionally, in the embodiment of FIG. 3, the proximal loop 5 resideson the cannula 2 just prior to the proximal opening 4 of the cannula 2.

[0077] The central passage of the cannula should have a diameter largeenough to allow sliding passage of two surgical sutures therethrough.The distal opening 11 of the cannula should also have a diameter largeenough to allow engagement with the tip of the spinal needle for thepurpose of passage of the suture between the cannula and the needle.

[0078] In the embodiment of FIG. 1, the cannula 2 from its distalopening 11 to the point at which it enters the handle ranges in lengthfrom about 6.0 cm to about 20.0 cm, and more preferably 12.0 cm inlength. The opening of the cannula 2 is preferably from about 0.08 cm toabout 0.32 cm in width, and more preferably 0.16 cm in width. The wallof the cannula 2 is preferably from about 0.01 cm to about 0.05 cm inthickness, and more preferably, 0.0254 cm in thickness. The handlepreferably has a width ranging from about 0.64 cm to about 1.28 cm, andmore preferably 0.96 cm in width.

[0079] The wire of the wire loops as shown in FIG. 5 ranges from about0.10 to about 0.14 cm in diameter “a” and is preferably attached to thehandle by a mounting structure 12 about 0.1 to about 0.4 cm in height“h.”

[0080] In the embodiment of the invention illustrated in FIG. 6, thesuture passer 1 is similar to the invention illustrated in FIG. 3;however, the cannula 2 is flush with the flattened surface of the handle1 bearing the wire loops 5 and 6. A segmented piece 13 upon which theproximal loop 5 resides attaches the cannula 2 to the handle 3. Theproximal opening 10 of the cannula opens on the proximal side of thesegmented piece 13.

[0081] In all of the embodiments of the meniscus suture passer 1, thedistal loop 6 may be fitted anywhere along the length of the handle.However, it is preferable that the distal loop 6 be fitted about halfwaybetween the ends of the handle of the suture passer.

[0082] In yet another embodiment of the invention, shown in FIG. 7,first guide means comprises a single turn open loop lying in a firstplane, with the first plane disposed perpendicularly to thelongitudinally extending hollow cannula, and a second guide meanscomprising a plurality of bent fingers lying in parallel planes. Theplanes are parallel to each other and are perpendicular to thelongitudinally extending hollow cannula. The bent fingers may bealternately bent in opposite directions. As shown in FIGS. 7A and 7B,the second guide means may have 3 bent fingers 14, 15, 16.

[0083] The suture passer 1 may be made out of either plastic or metal,or a combination thereof, with the handle, loops, or cannula beingplastic, metal or any combination thereof. The cannula of the meniscalsuture passer may be semi-rigid. The cannula should be rigid enough tostabilize the inner tear of the meniscus during the insertion of theepidural needle. Additionally, if made of plastic, the cannula should bemalleable enough that it can be bent by hand without the need of aspecial bender. After the cannula is bent it should not spring back.Because of its malleable characteristics, the plastic material is lesslikely to damage the articular surface. If the suture passer is entirelymade out of plastic, the entire suture passer device can be injectionmolded as a single unit. If the handle is made out of plastic material,the loop or the finger projections may be molded as an integral part ofthe handle.

[0084] If the suture passer is made out of metal, however, the loops maybe screwed, riveted, or soldered onto the handle of the suture passer.

[0085] Frequently, surgical instruments and suturing devices must beadaptable to the environment or conditions in which they are being used.More specifically, because of the location of the menisci in theshoulder and in the knee, or because there is limited space in that partof the body being repaired for the placement of surgical tools,especially during suturing, it is frequently advisable to adjust theshape of the cannula of the suture passer or to bend the needles beingused during suturing to allow for the positioning of the instrumentsinto or through the surgical incision to allow for maximum visibility onthe part of the operating team and to avoid crowding of the incisionarea which would hinder the operating team.

[0086] Preferably included in the surgical repair kit when the cannulais made out of metal is a cannula bender. The cannula bender may be usedto bend the cannula without kinking the cannula.

[0087] The cannula bender 30 shown in FIGS. 12 and 13 is designed tobend a cannula to a desired curvature. It is different from the existingtube or cannula benders in that it allows the cannula to be bent tovarious radii of curvature. The cannula bender 30 can also bend thecannula in more than one plane.

[0088] The cannula bender 30 consists of a base 31 with an approximatediameter of from about 1.25 cm to about 8 cm, with a preferred diameterof about 3.8 cm. The base which is preferably curved, circular, or ovalin shape, serves as a handle by which the cannula bender is grasped. Thebase 31 may be knurled or striated to provide for a better grip.

[0089] There are symmetrical curved bolsters having steps 33, 34, 35,and 36 on top of the base. The stepped configuration provides the highersteps 34, 35 with a smaller radius of curvature. The steps range inheight from about 0.6 cm to about 4 cm in height, with a preferredheight of about 1 cm. (Two steps are illustrated but more can beprovided).

[0090] The cannula 2 is bent against the bolsters 33 or 36 to create thedesired curvature. If a greater degree of curvature is required thecannula may be bent against the higher bolsters 34 or 35 that have asmaller radius. The symmetry of the bolsters allows the cannula to bebent to the right or to the left without having to rotate the cannulabender. This allows for a faster, easier use of the cannula bendershould the need arise during surgery.

[0091] The cannula can be bent again in a different plane by rotatingthe cannula while maintaining the cannula bender in the sameorientation. The pre-bent cannula can be contoured against the bolsterin a second plane as long as the curvature is less than the height ofthe step of the bolster.

[0092] The entire cannula does not have to be bent, if at all. Thepurpose of bending the cannula is for the convenience of the surgeon inpassing the suture to and from the needle(s) to the suture passer, andto manipulate the suture passer, to reach an area in the cavity or jointthat would otherwise be inaccessible by a straig cannula.

[0093] In addition to the suture passer device, the surgical repair kitalso contains at least two and preferably three needles. It is preferredthat the needles be epidural needles 18, two of which are of the samelength, e.g., about 3.5 inches in length, and one of which is longer,e.g., about 4.75 inches in length. It is also preferred that the needlesbe 18 gauge needles. As seen in FIG. 8A, a spinal needle 17 has abevelled tip which, during repair of the meniscus, may accidentlylacerate the articular cartilage. In contrast, as seen in FIG. 8B, theepidural needle 18 has a Huber tip. With the epidural needle it iseasier to advance the needle through tough tissue by using a twistingmotion. The “rounded” tip of the epidural needle is less likely tolacerate the articular surface.

[0094] The surgical repair kit preferably comes with at least twoneedles of the same length because the needle which is inserted firstbecomes blunt after several insertions. The insertion of the second,generally longer, epidural needle is easier with the use of the parallelneedle guide 19 as shown in FIGS. 8 and 9. (Longer and shorter needlesare utilized to prevent the hubs 29A of adjacent needles frominterferring with one another by staggering the hub distance from thepatient's body). The parallel needle guide allows for the properalignment of the needles through which the suture will pass. Theparallel needle guide is a series of at least three, and preferably fourto five hollow tube shaped units 20 longitudinally adhered to each otherone on top of the other in a parallel formation. The opening or diameterof each tube shaped unit should be large enough to allow for the passageof an 18 or 21 gauge needle to pass through. The parallel needle guidemay be made out of plastic, paper or metal. The parallel needle guidemay be from a mold, or the individual tubes may be individually formedand bonded to each other. Any method of forming the structure isacceptable.

[0095] Additionally, there is at least one stylet typified by stylet 29shown in FIG. 11 in the surgical repair kit for each needle included inthe repair kit. The stylet is kept in the needle until the needle ispassed through the meniscus. This prevents the needle(s) from beingclogged with tissue and cartilage as it is pushed through the cartilage.A needle clogged with tissue will, of course, not allow the suture to bepassed through the needle to the suture passer.

[0096] A template (not shown) is preferably included in the surgicalrepair kit. This template, which may be printed on the back of thesurgical repair kit container, may be printed on a paper guide insidethe meniscal repair kit, or may be provided on, or as, a plastic guide.The template is used as a guide for the bending of the cannula.

[0097] Each of the items included in the surgical repair kit is sterile.Additionally, each item in the surgical repair kit is preferablyindividually packaged in sterile plastic, paper, metal foil, orcombinations thereof. The packaging should be easy to open, so that thecontents thereof are not damaged or do not fall on the operating floorwhile opening. The content of the package and the packaging may besterilized with ethylene oxide or by radiation, or any otherconventional method for the sterilization of packaged elements.

[0098] The surgical repair kit which includes the suture passer, atleast two surgical needles of predetermined length, and at least onestylet for each needle, may also contain an optional third needle ofgreater length than the other two needles, the parallel needle guide,and a template. If the cannula is made of metal, a cannula bender may beincluded in the repair kit. While the repair kit may be used for anysurgery, the repair kit is extremely useful in meniscal repair kit.

[0099] In repairing the middle third of the meniscus, the arthroscope 37should enter through the ipsilateral portal 38 as shown in FIG. 14. Thesuture passer 1 should enter through the contralateral portal 39. Theepidural needle is loaded through the hole on one end of the needleguide using a one handed technique to avoid accidental puncture of thesurgeon's opposite hand.

[0100] There are three methods of identifying the insertion points forthe needles.

[0101] The first method is to view the meniscal tear with thearthroscope, with the synovial meniscal junction in view, and thenadvance the arthroscope to the synovial meniscal junction. The lightfrom the arthroscope will transilluminate the skin. The point ofinsertion of the epidural needle should be slightly distal to thislight.

[0102] The second method of determining where to insert the needles isto view the meniscal tear and to keep the synovial meniscal junction inview. Palpate along the joint line with a tip of a finger or a meniscalprobe. The area of maximal wall motion at the synovial meniscal junctionindicates the point at which the epidural needle should be inserted.

[0103] The third method is the easiest method in determining the needleinsertion point, if the synovial meniscal junction is accessible to thesuture passer. The tip of the suture passer is pushed against thesynovial meniscal junction and the skin is palpated, with the finger.The area of the tip will indicate the approximate location where theneedle should be inserted.

[0104] The needles may be advanced with a twisting motion if difficultyis encountered in penetrating the tough meniscal tissue. As shown inFIG. 15, the inner rim 40 of the meniscal tear 41 may be buttressed withthe tip of the cannula 2 of the suture passer to stabilize it againstthe advancing needle 18.

[0105] Using the parallel needle guide, two epidural needles areinserted through the guide and across the meniscal tear with the longepidural needle 42 being inserted through the needle guide at a desiredseparation distance from the shorter needle (as shown in FIG. 16). Thislonger needle is inserted through the meniscal tissue, preferably behindthe shorter needle. The stylets are removed from the needles. A sutureis passed through the “first” needle. The tip of the cannula of thesuture passer is introduced into the joint cavity through a smallincision. The distal opening of the cannula is placed at or near theopening of the needle through which the suture has been passed. Thereare areas in the joint cavity, although visible through the arthroscopewhich are not accessible with a straight cannula. Consequently, prior tothe introduction of the suture passer, the cannula of the suture passermay be bent on the cannula bender. The curved cannula allows the surgeonto reach remote areas where the meniscus is being repaired.

[0106] In a preferred method for passing the suture from the cannula tothe needle, the needle, preferably an epidural needle with a Huber tip,engages the opening of the cannula (FIG. 17). The more posterior needleis advanced into the joint and captures the tip of the needle with thetip of the cannula. For ease of passage, it is preferable that thecannula and needle meet at about a 15°-30° angle. The opening of theneedle should be facing away from the apex of engagment between thecannula and the needle. The suture is passed directly from the cannulainto the tip of the needle or vice versa.

[0107] By careful manipulation, the suture 43 is fed through the needleand into the cannula. With the tip of the cannula and the needlesecurely engaged and the suture is fed (FIG. 18) into the hub of theneedle until it exits the proximal opening of the handle of the suturepasser. It is advisable to pull the suture three quarters of the waythrough. The suture close to the opening 4 of the cannula is broughtforward to engage the proximal loop. The suture is looped onto thedistal guide and is threaded back into the cannula. The suture isengaged onto the proximal guide (FIG. 19).

[0108] The first needle is removed, and with the two limbs of the sutureheld separately by the proximal and distal loops, one limb of the sutureis advanced by sliding the suture with the index finger over the topsurface of the handle so that the suture emerges from the tip of thecannula (FIG. 20). The suture, via the suture passer, is now fullycontrollable with one hand. The tip of the second needle and the tip ofthe cannula are brought into close proximity and the suture is passedfrom the loaded suture passer into the opening of the second needle andthrough the second needle. The suture is advanced until it exits fromthe hub of the second needle (FIG. 21). The second needle is partiallyremoved so that the tip of the second needle is buried within the softtissue 44 (FIG. 22). The suture is disengaged from the guides on thehandle of the suture passer.

[0109] While grabbing both ends of the suture, the suture is pulledthrough the cannula into the joint 45 (FIG. 23). With the second needlestill in place, a stab incision is made along the shaft of the secondneedle down to the level of the joint capsule 47 but not beyond (FIG.24). The second needle is removed and the soft tissue is dissected allthe way down to the joint capsule by spreading the soft tissue with apair of small forceps 48 (FIG. 25). The other limb of the suture is thenretrieved through this “stab incision” with a meniscal probe 49 (FIG.26) and the sutures are tied after all of the sutures have been put intoplace.

[0110] For a meniscal tear in the more posterior position, the straightcannula can enter through the ipsilateral portal to reach the posteriorhorn of the meniscus (FIG. 27a). The cannula can also be contoured toreach a specific zone of the meniscus with the use of the cannula benderand the template for the various zones (FIG. 27b).

[0111] During repair of the meniscus, if the tip of the cannula cannotengage the tip of the needle during initial passage of the suture, thesuture may be fed through the posterior needle into the joint. Thesuture may then be retrieved with a snap or a suture retriever 50 (FIG.28). The first needle is removed and the suture is fed into the cannulain a retrograde direction (FIG. 29). The cannula is advanced into thejoint along the suture. The suture is then looped onto the distal guideand threaded back into the cannula until it reaches the tip of thecannula. The suture is then engaged onto the proximal guide (FIG. 30).

[0112] The suture is then advanced into the tip of the second needleunder arthroscopic visualization (FIG. 31). The suture is advanced untilit exits from the hub of the second needle. The second needle isslightly pulled back so that the tip of the needle is buried within thesoft tissue. The suture is disengaged from the guides on the handle ofthe suture passer and the suture is pulled through the cannula into thejoint.

[0113] The suture passer can also be used to pass the suture from thesuture passer to the hollow needles, instead of vice versa. The suturepasser is loaded with a suture so that the suture engages the first andsecond guide means with the “beginning” and “terminal” ends of thesuture protruding from the distal opening of the hollow cannula. Thebeginning end of the suture is fed from the distal opening of the hollowcannula through the opening of the first hollow needle until it exitsthe first hollow needle. The terminal end of the suture is passed fromthe distal opening of the hollow cannula through the opening of thesecond hollow needle until it exits the second hollow needle. The sutureis then completely disengaged from the suture passer, the suture passeris removed, both hollow needles are removed and the suture is tightenedand tied.

[0114] By maneuvering the tip of the needle with one hand and thecannula in the other when both tips are in close proximity, the suturemay be advanced.

[0115] In another method, the suture protrudes from the cannula by about½ to 1 centimeter. By manipulating the tip of the cannula with the tipof the needle, one can engage the suture into the tip of the needle andadvance the suture.

[0116] An arthroscopic video camera may be used to visualize thesuturing. The surgeon manipulates the suture preferably while viewing avideo monitor connected to the camera.

[0117] A recommended suture for use is the Ethicon “O” PDS suture. Thelength of the suture should be at least 27 inches and preferably 36inches in length. With other types of monofilament suture, the strandtends to be curled when removed from the packaging. It is necessary tostraighten out the suture prior to use, as the ends of the suture mustbe straight for ease of passage of the suture between the cannula andthe needle.

[0118] It is preferable that the suture being used have distinctmarkings to give an enhanced visual indication of the movement of thesuture. Different types and colors of markings along the length of thesuture will indicate how much suture has been advanced. It is preferredthat the suture have distinct markings at the beginning and terminalends of the suture, which could indicate the length of the suture whichhas been advanced.

[0119] If the meniscal tear is large, the repair operation should beginat the anterior portion of the tear. After the placement of the anteriorsuture, it will be easier to work along the anterior joint line to theposterior part of the tear. The medial meniscus is repaired with theknee in near extension or slight flexion. The lateral meniscus isrepaired with the knee in 45° to 90° flexion.

[0120] The foregoing description of the preferred embodiments of theinvention has been presented for the purposes of illustration anddescription. It is not intended to be exhaustive or to limit theinvention to the precise forms disclosed. Many modifications andvariations are possible in light of the above teachings. It is intendedthat the scope of the invention not be limited by this detaileddescription.

What is claimed is:
 1. A suture passer comprising: a longitudinallyextending hollow cannula having a central passage slidingly receivableof a surgical suture; a manually graspable handle connected to saidhollow cannula for manipulation thereof, said handle having an uppersurface; first guide means, connected to said upper surface of saidhandle, proximate a proximal end of said handle, for releasably,guidingly, holding said surgical suture; second guide means, connectedto said upper surface of said handle, distal to said first guide means,for releasably, guidingly, holding said surgical suture.
 2. The suturepasser according to claim 1, wherein said hollow cannula is connected tosaid upper surface of said handle and said hollow cannula terminates ata rearward opening intermediate said first and second guide means. 3.The suture passer according to claim 1, wherein said hollow cannula isreceived within a bore formed in said handle, said bore terminating atan opening in said upper surface of said handle intermediate said firstand second guide means.
 4. The suture passer according to claim 1,wherein said first guide means comprises a single turn open loop, havinga first axis of rotation of said loop, and said second guide meanscomprises a one and one-half turn open loop, having a second axis ofrotation of said loop.
 5. The suture passer according to claim 4,wherein said first axis of rotation and said second axis of rotation areparallel to one another.
 6. The suture passer according to claim 5,wherein said first axis of rotation is transverse to said longitudinallyextending hollow cannula.
 7. The suture passer according to claim 5,wherein said first axis of rotation is parallel to said longitudinallyextending hollow cannula.
 8. The suture passer according to claim 1,wherein said first guide means comprises a single turn open loop lyingin a first plane, said first plane disposed perpendicular to saidlongitudinally extending hollow cannula; said second guide meanscomprises A plurality of bent fingers, each of said bent fingers lyingin a plane, each of said planes parallel to one another andperpendicular to said longitudinally extending hollow cannula.
 9. Thesuture passer according to claim 8, wherein said plurality of bentfingers are alternately bent in opposite directions.
 10. The suturepasser according to claim 9, wherein said second guide means comprisesthree bent fingers.
 11. The suture passer according to claim 1, whereinsaid central passage of said cannula has a diameter sufficiently largeto allow sliding passage of two surgical sutures therethrough.
 12. Thesuture passer according to claim 1, wherein said cannula is metal. 13.The suture passer according to claim 1, wherein said cannula is plastic.14. The suture passer according to claim 1, wherein said handle isprovided with grip means for enhancing the manual grasping thereof. 15.The suture passer according to claim 14, wherein said grip means is aknurled surface.
 16. A surgical repair kit comprising: a suture passercomprising: a longitudinally extending hollow cannula having a centralpassage slidingly receivable of a surgical suture; a manually graspablehandle connected to said hollow cannula for manipulation thereof, saidhandle having an upper surface; first guide means, connected to saidupper surface of said handle, proximate a proximal end of said handle,for releasably, guidingly, holding said surgical suture; second guidemeans, connected to said upper surface of said handle, distal to saidfirst guide means, for releasably, guidingly, holding said surgicalsuture; at least two surgical needles of predetermined length; and atleast one stylet for each surgical needle.
 17. The surgical repair kitaccording to claim 16, wherein said surgical needles are epiduralneedles.
 18. The surgical repair kit according to claim 17, wherein saidepidural needles have a Huber tip.
 19. The surgical repair kit accordingto claim 16, further comprising a third needle.
 20. The surgical repairkit according to claim 19, wherein said third needle has a lengthgreater than that of said surgical needles.
 21. The surgical repair kitaccording to claim 16, wherein said suture passer comprises a metalcannula.
 22. The surgical repair kit according to claim 21, furthercomprising a cannula bender for bending said metal cannula, said cannulabender comprising a base, a pair of upwardly stepped symmetricalbolsters positioned on top of said base allowing said cannula to be bentto the right or to the left, each step of each bolster having apredetermined radius of curvature wherein the radius of curvature ofeach step is smaller than the radius of curvature of the stepimmediately below.
 23. The surgical repair kit, according to claim 22,wherein the height of each step is substantially greater than thediameter of the cannula.
 24. The surgical repair kit according to claim16, further comprising a parallel needle guide for guiding said needles,said parallel needle guide comprising at least three longitudinallyextending, hollow, tube-shaped units longitudinally adhered to eachother, in a plane, parallel to one another, each of said tube-shapedunits slidingly receivable of a surgical needle therethrough.
 25. Amethod for suturing internal tissue at least partially accessiblethrough a body cavity, said method comprising the steps of: (A)providing at least one suture having a first limb and a second limb; (B)providing a suture passer comprising a longitudinally extending hollowcannula having a distal opening, a proximal opening and a centralpassage slidingly receivable of a surgical suture; (C) introducing saiddistal end of said cannula into a body cavity at least partiallyaccessing internal tissue to be sutured; (D) identifying a firstinsertion site for passing a first limb of a suture through saidinternal tissue to be sutured; (E) inserting a first hollow needlethrough said first insertion site, said hollow needle extending fromoutside said body through said first insertion site into said bodycavity; (F) identifying a second insertion site for passing a secondlimb of said suture through said internal tissue to be sutured; (G)inserting a second hollow needle through said second insertion site,said hollow needle extending from outside said body through said secondinsertion site into said body cavity; (H) passing said second limb ofsaid suture through said first hollow needle into said distal opening ofsaid cannula until it exits said proximal opening of said cannula; (I)feeding said second limb of said suture back into said cannula throughsaid proximal opening; (J) passing said second limb of said suturethrough said hollow cannula into said second hollow needle until itexits said needle external of the body; (K) drawing said suture throughsaid cannula into said body cavity; (L) removing said first and secondhollow needles by drawing the outwardly of said body cavity; (M) tyingsaid limbs of said suture; and (N) repeating steps (D)-(M) until asurgically sufficient number of sutures have been tied.
 26. The methodof suturing according to claim 25, wherein said method is performed forarthroscopic surgery.
 27. The method of suturing according to claim 25,wherein said method is performed for the repair of meniscal tears. 28.The method of suturing according to claim 27, wherein said firstinsertion site is identified by viewing the meniscal tear with anarthroscope, advancing the arthroscope to the synovial meniscaljunction, and transilluminating the skin with the light from thearthroscope, such that the site of insertion of the hollow needle willbe slightly distal to said light.
 29. The method of suturing accordingto claim 27, wherein said first insertion site is identified by viewingthe meniscal tear, keeping the synovial meniscal junction in view,palpating along the joint line with a tip of a finger or a meniscalprobe, such that the area of maximal wall motion at the synovialmeniscal junction will indicate the site at which the needle should beinserted.
 30. The method of suturing according to claim 27, wherein saidfirst insertion site is identified by pushing the distal end of saidcannula against the synovial meniscal junction, and palpating the skin,such that the cannula will indicate the site at which the needle shouldbe inserted.
 31. The method of suturing according to claim 27, wherein aparallel needle guide is used to determine said second insertion site,said parallel needle guide comprising at least three longitudinallyextending, hollow tube-shaped units longitudinally adhered to eachother, in a plane, parallel to one another, wherein each of saidtube-shaped units can slidingly receive a surgical needle therethrough.32. The method of suturing according to claim 27, wherein said firsthollow needle and said second hollow needle each comprise a stylet whichis removed following the insertion of said needles through said internaltissue.
 33. The method of suturing according to claim 25, furthercomprising using a video monitor to visualize the suturing of theinternal tissue.
 34. The method of suturing according to claim 25,wherein an arthroscopic video camera is used to visualize said suturing.35. The method of suturing according to claim 25, wherein said suturehas distinct markings along the said suture, indicating the length ofsaid suture that has been advanced.
 36. The method of suturing accordingto claim 25, wherein said distal end of said cannula is inserted intosaid body cavity through a surgical incision.
 37. The method of suturingaccording to claim 25, wherein said suture passer further comprises amanually graspable handle connected to said hollow cannula formanipulation thereof, said handle having an upper surface, first guidemeans, connected to said upper surface of said handle, proximate aproximal end of said handle, for releasably, guidingly, holding saidsurgical suture, second guide means, connected to said upper surface ofsaid handle, distal to said first guide means, for releasably,guidingly, holding said surgical suture, said proximal opening of saidcannula intermediate said first and second guide means; and said methodfurther comprises: a step (H′), intermediate steps (H) and (I), ofengaging said second limb of said suture with said first and then saidsecond guide means of said suture passer; and a step (J′), intermediatesteps (J) and (K), of disengaging said suture from said first and secondguide means of said suture passer.
 38. The method of suturing accordingto claim 37, wherein said first and second limbs of the suture areseparated by the first guide means and the second guide means, and onelimb of the suture is advanced by sliding the suture over the topsurface of the handle of the suture passer.
 39. The method of suturingaccording to claim 38, wherein said suture passer is grasped by saidhandle in one hand of the surgeon and said one limb of the suture isadvanced by applying longitudinal force with a finger or thumb so thatfriction between said finger or thumb and said suture will cause saidsuture to slide along said top surface of said handle, into or out ofsaid cannula.
 40. The method of suturing according to claim 39, whereinsaid suture passer is grasped by and said limb of said suture ismanipulated by a single hand of a surgeon performing the suturing.
 41. Amethod for suturing internal tissue at least partially accessiblethrough a body cavity, said method comprising the steps of: (A)providing at least one suture having a first limb and a second limb; (B)providing a suture passer comprising a longitudinally extending hollowcannula having a distal opening, a proximal opening and a centralpassage slidingly receivable of a surgical suture; (C) loading saidsuture passer with a surgical suture such that an end of said first limbof said suture and an end of said second limb of said suture eachprotrude from said distal end of said cannula; (D) introducing saiddistal end of said cannula into a body cavity at least partiallyaccessing internal tissue to be sutured; (E) identifying a firstinsertion site for passing said first limb of said suture through saidinternal tissue to be sutured; (F) inserting a first hollow needlethrough said first insertion site, said hollow needle extending fromoutside said body through said first insertion site into said bodycavity; (G) identifying a second insertion site for passing a secondlimb of said suture through said internal tissue to be sutured; (H)inserting a second hollow needle through said second insertion site,said hollow needle extending from outside of said body through saidsecond insertion site into said body cavity; (I) introducing said end ofsaid first limb of said suture into said first hollow needle until itexits said first hollow needle outside said body; (J) introducing saidend of said second limb of said suture into said second hollow needleuntil it exits said second hollow needle outside said body; (K) drawingsaid suture through said cannula into said body cavity; (L) removingsaid first and second hollow needles by drawing them outwardly of saidbody cavity; (M) tying said limbs of said suture; and (N) repeatingsteps (C)-(M) until a surgically sufficient number of sutures have beentied.
 42. The method of suturing according to claim 41, wherein saidmethod is performed for arthroscopic surgery.
 43. The method of suturingaccording to claim 41, wherein said method is performed for the repairof meniscal tears.
 44. The method of suturing according to claim 43,wherein said first insertion site is identified by viewing the meniscaltear with an arthroscope, advancing the arthroscope to the synovialmeniscal junction, and transilluminating the skin with the light fromthe arthroscope, such that the site of insertion of the hollow needlewill be slightly distal to said light.
 45. The method of suturingaccording to claim 43, wherein said first insertion site is identifiedby viewing the meniscal tear, keeping the synovial meniscal junction inview, and palpating along the joint line with a tip of a finger or ameniscal probe, such that the area of maximal wall motion at thesynovial meniscal junction will indicate the site at which the needleshould be inserted.
 46. The method of suturing according to claim 43,wherein said first insertion site is identified by pushing the distalend of said cannula against the synovial meniscal junction, andpalpating the skin, such that the cannula will indicate the site atwhich the needle should be inserted.
 47. The method of suturingaccording to claim 43, wherein a parallel needle guide is used todetermine said second insertion site, said parallel needle guidecomprising at least three longitudinally extending, hollow tube-shapedunits longitudinally adhered to each other, in a plane, parallel to oneanother, wherein each of said tube-shaped units can slidingly receive asurgical needle therethrough.
 48. The method of suturing according toclaim 43, wherein said first hollow needle and said second hollow needleeach comprise a stylet which is removed following the insertion of saidneedles through said internal tissue.
 49. The method of suturingaccording to claim 41, further comprising using a video monitor tovisualize the suturing of the internal tissue.
 50. The method ofsuturing according to claim 41, wherein an arthroscopic video camera isused to visualize said suturing.
 51. The method of suturing according toclaim 41, wherein said suture has distinct markings along the saidsuture, indicating the length of said suture that has been advanced. 52.The method of suturing according to claim 41, wherein said distal end ofsaid cannula is inserted into said body cavity through a surgicalincision.
 53. The method of suturing according to claim 41, wherein saidsuture passer further comprises a manually graspable handle connected tosaid hollow cannula for manipulation thereof, said handle having anupper surface, first guide means, connected to said upper surface ofsaid handle, proximate a proximal end of said handle, for releasable,guidingly, holding said surgical suture, second guide means, connectedto said upper surface of said handle, distal to said first guide means,for releasably, guidingly, holding said surgical suture, said proximalopening of said cannula intermediate said first and second guide means;and said method further comprises: in said step (C), passing said suturethrough said first and second guide means; and a step (J′), intermediatesteps (J) and (K), of disengaging said suture from said first and secondguide means of said suture passer.
 54. The method of suturing accordingto claim 53, wherein said first and second limbs of the suture areseparated by the first guide means and the second guide means, and onelimb of the suture is advanced by sliding the suture over the topsurface of the handle of the suture passer.
 55. The method of suturingaccording to claim 54, wherein said suture passer is grasped by saidhandle in one hand of the surgeon and said one limb of the suture isadvanced by applying longitudinal force with a finger or thumb so thatfriction between said finger or thumb and said suture will cause saidsuture to slide along said top surface of said handle, into or out ofsaid cannula.
 56. The method of suturing according to claim 55, whereinsaid suture passer is grasped by and said limb of said suture ismanipulated by a single hand of a surgeon performing the suturing.
 57. Asuture for suturing tissue comprising visible markings on said suturefor a predetermined distance on each end portion of each limb of thesuture.
 58. The suture of claim 57, wherein the markings on each endportion of said suture are different from each other.
 59. The suture ofclaim 58, wherein the markings of said suture comprise contrastingcolors.
 60. A cannula bender comprising a base, a pair of upwardlystepped symmetrical bolsters positioned on top of said base allowingsaid cannula to be bent to the right or to the left, each step of eachbolster having a predetermined radius of curvature wherein the radius ofcurvature of each step is smaller than the radius of curvature of thestep immediately below.
 61. The cannula bender of claim 60, wherein theheight of each step is substantially greater than the diameter of thecannula.